JOHNSON & JOHNSON v. SAMSUNG BIOEPIS CO. LTD.
3:25-cv-01439
D.N.J.Apr 28, 2025Background
- Johnson & Johnson and Janssen ("Plaintiffs") developed and market Stelara, a blockbuster biologic drug (ustekinumab), used for immune-mediated conditions.
- Samsung Bioepis ("Samsung") developed a biosimilar (Pyzchiva) and, after litigation over patents, entered a Settlement Agreement with Plaintiffs permitting conditional, limited entry of Samsung's biosimilar to the U.S. market from February 22, 2025.
- The Settlement Agreement restricts Samsung's ability to sublicense its rights, allowing sublicensing only in three specific scenarios, such as to commercialization partners acting "on behalf of" Samsung.
- Samsung entered deals with Sandoz (as commercializer) and then sublicensed rights to Quallent (a Cigna subsidiary) as a "private label distributor" under Quallent’s own label.
- Plaintiffs sued Samsung for breach of contract and breach of the implied covenant of good faith and fair dealing, seeking a preliminary injunction to block the Quallent product's launch and compel specific disclosures from Samsung.
- The court found Plaintiffs likely to succeed on the merits of both contract and good faith claims but denied injunctive relief because Plaintiffs failed to show irreparable harm.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Did Samsung breach the Settlement Agreement by sublicensing to Quallent? | The Quallent sublicense exceeded the Settlement's narrow exceptions and violated the anti-assignment provision. | Quallent falls within "commercialization partner" exception (acting on Samsung's behalf). | Samsung likely breached; Quallent was not acting "on behalf of" Samsung as required. |
| Breach of implied covenant of good faith and fair dealing | Samsung frustrated Plaintiffs’ contract purpose by expanding sublicensing to private label entities like Quallent. | No breach or duplicative; actions consistent with agreement terms. | Plaintiffs likely to succeed; Samsung's actions likely inequitably undermined the agreement. |
| Irreparable harm justifying preliminary injunction | Market share losses from private label entry are unique and not quantifiable due to conglomerate control (Cigna). | Any damages are economic and calculable given available market data; no irreparable harm. | No irreparable harm shown; monetary damages sufficient. |
| Samsung’s disclosure obligations | Not disclosing full agreements with Sandoz/Quallent was a separate breach requiring urgent relief. | No causal nexus between disclosure breach and alleged market harm; discovery can resolve. | No showing of irreparable harm from delayed disclosure; not warranting injunction. |
Key Cases Cited
- Kos Pharms., Inc. v. Andrx Corp., 369 F.3d 700 (3d Cir. 2004) (sets standard for preliminary injunctions, emphasizing irreparable harm)
- Reilly v. City of Harrisburg, 858 F.3d 173 (3d Cir. 2017) (framework for weighing all four preliminary injunction factors)
- Acierno v. New Castle Cnty., 40 F.3d 645 (3d Cir. 1994) (preliminary injunction maintains status quo)
- Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578 (3d Cir. 2002) (loss of market share may be irreparable under specific facts)
- Sons of Thunder, Inc. v. Borden, Inc., 690 A.2d 575 (N.J. 1997) (implied covenant prohibits frustrating contract benefits)
- Wade v. Kessler Inst., 798 A.2d 1251 (N.J. 2002) (delineates breach of implied covenant from express contract term)